The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Joshua A. Beckman, MD, Brigham and Women's Hospital Identifier:
First received: September 24, 2008
Last updated: August 15, 2013
Last verified: August 2013

This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.

Condition Intervention Phase
Metabolic Syndrome
Drug: acipimox
Drug: matching placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Absolute difference in flow-mediated, endothelium-dependent vasodilation of the brachial artery between the test agent and placebo [ Time Frame: following 1 week of drug/placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: acipimox
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
Other Name: Olbetam
Placebo Comparator: 2 Drug: matching placebo
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit

Detailed Description:

We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT and eNOS phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:

    • abdominal obesity
    • elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL)
    • low HDL
    • elevated fasting blood triglycerides (> 150 mg/dL)
    • hypertension (BP > 140/90 mm HG)
  • Normal cardiovascular examination

Exclusion Criteria:

  • Diabetes mellitus
  • Untreated hypercholesterolemia (LDL > 75th percentile for age)
  • Cigarette smoking within 1 year
  • Renal insufficiency (creatinine > 1.4 mg/dl)
  • Blood dyscrasia
  • Hepatic dysfunction (ALT > 2x normal)
  • Evident coronary/peripheral atherosclerosis
  Contacts and Locations
Please refer to this study by its identifier: NCT00759291

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Joshua A. Beckman, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Joshua A. Beckman, MD, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital Identifier: NCT00759291     History of Changes
Other Study ID Numbers: 2005P-001861
Study First Received: September 24, 2008
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
free fatty acids
endothelium-dependent vasodilation
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses processed this record on April 17, 2014